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Feasibility of using a transition diabetes team to commence injectable therapies postdischarge from a tertiary hospital: a pilot, randomised controlled trial

Objectives This study aimed to investigate if the use of a transition team was feasible for patients with diabetes being discharged from hospital on injectable diabetes therapies. Design Pilot, randomised controlled trial. Setting The trial was conducted between 2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider. Participants Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to transition team or standard care. The transition team received in-home diabetes education 24–48 hours postdischarge, with endocrinologist review 2–4 weeks and 16 weeks postdischarge. Main outcome measures The primary outcome was feasibility, defined by percentage of patients successfully receiving the intervention. Secondary outcomes included safety, defined by hospital readmission and emergency department presentations within 16 weeks postrandomisation, and treatment satisfaction, measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS) and change in haemoglobin A1c (HbA1c) throughout the study. Results The intervention was deemed feasible (85% (95% CI 73% to 94%)). No difference in safety between groups was detected. No difference in change in HbA1c between groups was detected (standard care median HbA1c −1.5% (IQR −3.7% to −0.2%) vs transition team median HbA1c −1.9% (IQR −3.8% to −0.2%), p=0.83). There was a trend towards reduced LOS in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5–12); transition team median LOS 6 (IQR 3–12), p=0.06). There was a significant improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5–16); transition team DTSQ change version median 15 (IQR 10–17.5), p=0.047), although interpretability is limited by missing data. Conclusion This study demonstrated that the use of a novel transition diabetes team is a feasible alternative model of care.


Article Summary: Strengths and Limitations in this Study
• A strength of this study was the successful collaboration of two large organisations providing support for the transition of care from hospital to home. Daily challenges in coordinating team members across organisations to achieve the same goals was evident throughout the trial. Despite this, the current study recruited a large number of patients. • We acknowledge the limitations of the study. Eight patients in each group did not have follow-up HbA1c measurements, despite active encouragement. • The number of missing DTSQc questionnaires may have limited interpretability of DTSQc results. The follow-up DTSQc was completed by 40 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team patients, despite the best efforts of investigators to obtain completed DTSQc questionnaires. We believe the non-random nature of missing data was largely due to factors related to the transition team group, particularly difficulties involved in attending appointments at hospital. However, it may be that patients failing to complete the DTSQc were less satisfied with treatment, suggesting that this was more likely in the transition team group. A significantly higher number of male participants failed to complete the DTSQc, and missing data were higher in those patients with hypertension and dyslipidaemia. The difficulty in obtaining this data raises concerns about the feasibility of using this method to assess treatment satisfaction in patients recently hospitalised with acute illness. • Withdrawal of participants from the transition team in hospital prior to the intervention may reflect reluctance in hospitalized patients to accept health providers entering their home, which may be a limitation of this model. Despite relative stability or a slight decline in diabetes-related mortality (1), global prevalence of diabetes is rising (2). Consequently, health care costs related to diabetes continue to increase over time (3).
It has been demonstrated that 34% of hospital inpatients aged over 54 attending a tertiary hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 2 diabetes have longer hospital length of stay and higher mortality rates compared to those without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemic control at the time of hospital admission, often result in the need for intensification with injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an opportunity to identify those with poor glycaemic control and optimise diabetes management (8). However, commencement of injectable therapies can be difficult in the context of concurrent acute illness.
Guidelines recommend that patients are required to demonstrate self-management with injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling patients to effectively self-manage, and assists in optimising glycaemic control post-discharge (10). However, diabetes education in the hospital setting is subject to a number of limitations including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes education may prove more effective based on understanding a patient's life context and allowing adaptation of self-management routines such as timing of injection, sharps disposal and medication storage to suit the patient's home environment (12).
This pilot study developed and evaluated the use of a transition team comprising in-home diabetes education by a credentialed diabetes educator (CDE), and early post-discharge assessment by an endocrinologist. We hypothesized that the proposed intervention would be feasible and would not negatively affect patient satisfaction when compared to standard care.

Participants
Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, were screened for the study, and randomised to receive the intervention or standard care after providing informed consent.
Participant inclusion criteria: • Type 2 diabetes, • Age greater than 18 years, • Need to start or change insulin or other injectable therapy, therefore requiring a credentialed diabetes educator (CDE) to provide education prior to discharge, • Ability to be contactable by telephone, • Medically stable and awaiting diabetes education, • Reside within a 30-minute travel radius of the hospital. This initial criterion was later abandoned and the decision to provide home care in the patient's residence was placed at discretion of the CDE, • Ability to attend hospital for outpatient follow-up, • Stable glycaemia defined as blood glucose levels between 5-15 mmol/L in the 24 hours prior to randomisation.
Participant exclusion criteria: • Participants who did not fulfil inclusion criteria, • Participants unable to provide informed consent.

Randomisation
Participants were randomised in a 1:1 ratio using permuted block randomisation, by an investigator without patient contact. Group allocations were concealed by writing allocations on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant given their allocation after informed consent was obtained. Due to the difference in treatment protocols, the study was open label to the participants and investigators.

Patient and Public Involvement
Changes in diabetes management, including initiation of new injectable medications, are often required during hospitalisation, and good glycaemic control is important during admission and post-discharge. Patients must be actively involved in changes to diabetes management, and require education regarding therapy changes and administration of injectable medications. Effective education of patients can be difficult in the hospital setting, particularly in the setting of concurrent acute illness. It is subject to a number of limitations including acute Patients were not involved in the original study design, and involvement of patients in recruitment was impractical as patients were hospitalised at the time of recruitment. However, during participation in the trial some intervention group patients expressed difficulty keeping their hospital appointment for endocrinologist follow-up. In response, a protocol for following up these patients using "telehealth" was established towards the end of the study. In this respect, patients had an influence on the study design and conduct of the study. A qualitative analysis of these patients' experiences and their perceptions of the intervention was performed, and this will be reported separately.
Following publication of our findings, the paper outlining study results will be sent to the study participants.

Standard Care
Participants randomised to standard care were educated by hospital credentialed diabetes educators (CDEs) prior to discharge. This comprised education regarding injectable therapy, storage, injection technique, and sharps disposal, and provision of additional resources when required. Additional resources included National Diabetes Services Scheme (NDSS) registration, supply of glucometer if required, written patient information regarding diabetes, and outpatient follow-up. Participants were discharged when medically appropriate and the inpatient team were satisfied that the participant could safely administer the injectable therapy. Prior to discharge, appropriate follow-up was organised. General Practitioners (GPs) were notified that participants had commenced or changed treatment.

Transition Team (intervention)
The transition team group participants received in-home education to start injectable therapy by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided with an appropriate glucometer in addition to education regarding medication, storage, injection technique, sharps disposal, NDSS registration, an education package in the relevant language, and CDE contact details.
Further contact with participants was based on CDE evaluation of the participant's capacity to self-manage injectable therapy. Once the CDE ascertained that participants were able to selfmanage without further intervention, the endocrinologist was notified. Participants were then linked with community CDE services, if necessary, for ongoing monitoring of selfmanagement.
Follow-up with the same endocrinologist was provided within four weeks and at 16 weeks post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist liaised with the participant's GP regarding changes to management and plans for ongoing follow-up after the 16-week visit.

Data collection
Baseline demographic, medication and medical data were collected and participants completed the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at enrolment. Follow-up data were collected at 16 weeks post-randomization, including rates of hospital readmissions and emergency presentations, length of hospital stay (LOS), glycaemic control as measured by HbA1c and treatment satisfaction using the DTSQ change version (DTSQc). Initial attempts to collect DTSQc questionnaires in the standard care group was by reply-paid mail, however after a limited response rate using this method, patients were contacted by phone. Study participation ceased at the 16-week endocrinology appointment, and final data collection occurred. Further follow-up for ongoing diabetes management was arranged at conclusion of the study.

Ethics
Ethics approval was obtained from the Austin hopsital human ethics committee and the community healthcare provider ethics committee. Each participant provided written informed consent.

Outcomes
The primary outcome measured was feasibility (proportion of participants in the transition team group completing the intervention as per protocol). Secondary outcomes were safety, as defined by hospital readmission and emergency department presentations within 16 weeks post-randomization, and patient satisfaction with care (measured by DTSQ). Exploratory outcomes were change in HbA1c and length of hospital stay.

Sample size determination
Due to the pilot nature of the study, the sample size estimation was based on precision arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of participants randomized into transition team group would be able to complete the intervention as per protocol), the sample of 55 participants randomized to the transition team group provides the precision (desired half-width of the 95% confidence interval) of 0.08.
The same number of participants was to be randomized to the standard care group, thus ensuring 80% power to detect potential medium-to-large effects of transition team intervention compared to the standard care (Cohen's d=0.55) assuming the settings of alpha=0.05. Thus, the total sample size for this study was proposed as 110 participants.

Statistical methods
The demographic and clinical characteristics of participants were summarized as medians (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical variables.
The feasibility of the intervention was estimated as a proportion of participants in the transition team group completing the intervention as per protocol with corresponding 95% confidence interval (95% CI).
The difference in safety profiles (diabetes related hospital presentation or admission) between two groups was investigated using Fisher's exact test.
DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression model with the DTSQ score at 16 weeks post-randomization as an output and treatment group and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the auxillary variables demonstrating significant association with the DTSQ data being missing, into the median regression model. Statistical analysis was performed on both intention to treat and per protocol bases. Per protocol analysis was deemed necessary to account for the patients who were initially assigned to transition team but withdrew prior to intervention; in this situation they received standard care.

Results
One hundred and five participants were randomised to transition team or standard care. Following initial drop outs, 103 participants received the intervention or standard care ( Figure  1). 55 participants randomised to the transition team and 48 participants randomised to receive standard care were included in the per protocol analysis (Figure 1). Participants randomised to the transition team withdrew for a variety of reasons such as decisions to change treatment, change of discharge destination, and changes to clinical status. For the purposes of the per protocol analysis, these participants crossed over to the standard care group.
Five participants withdrew following the home visit by the CDE but prior to completing the endocrinologist component of the intervention as they did not wish to participate.
One participant in the transition team group was unable to be followed up as they were being actively palliated for terminal malignancy, and one died before completion of the trial, for reasons unrelated to diabetes. One participant withdrew from the standard care group and one died before final data analysis in this group.
Baseline characteristics of participants are outlined in Table 1. No differences between groups at baseline were identified

Safety
There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard care) and one for inability to cope with insulin management at home due to change in social circumstances (transition team). Neither participant was admitted.

Patient satisfaction
A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline DTSQs value, the transition team median DTSQc value was 4 points higher than the standard care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team patients, thus the "missingness" of the data was not likely to be random. On the sensitivity analysis adjusted for the variables significantly associated with the missing DTSQc data at 16 weeks, the results remained qualitatively similar.

Length of Stay
There was a trend towards a reduced length of stay in the transition team group when analysed on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team median 6 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3. The most important finding in this trial was that a transition team to initiate injectable diabetes therapies following discharge is a feasible model of care. These data suggest that a transition team is safe and acceptable with a trend towards reduced length of hospital stay. Moreover, patients randomized to the transition team group had greater treatment satisfaction as demonstrated by a greater difference in DTSQc score.

Relationship with previous studies
The results pertaining to the quality of this intervention are supported by results from other studies examining home-based care in diabetes. The quality markers of this intervention include feasibility and objective measures of medical indices, including readmission and emergency presentation rates, change in HbA1c from baseline and length of stay, and patientreported outcomes.
We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when analysed on a per protocol basis. Future studies with greater numbers may demonstrate statistically significant reductions in length of hospital stay.
We demonstrated significant improvements in treatment satisfaction in the transition team group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical trials and validated in several languages. The status version (DTSQs) evaluates baseline satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of an intervention on satisfaction with treatment (14,15,16). Interpretability of this parameter is limited by missing data, discussed below.
Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with HbA1c reduction of over 2% in both groups. Importantly, there was no difference detected between the reduction in HbA1c in the transition team and the standard care group.
Other quality outcomes assessed included emergency department presentations and hospital readmissions. There were no significant differences in our study. This suggests that patient safety is unlikely to be compromised by delivery of home-based education. However, given the limited literature in this field, further studies with greater numbers would be necessary to validate these findings.
Strengths and limitations of this study: A strength of this study was the successful collaboration of two large organisations providing support for the transition of care from hospital to home. Daily challenges in coordinating team members across organisations to achieve the same goals was evident throughout the trial. Despite this, the current study recruited a large number of patients.
We acknowledge the limitations of the study. Eight patients in each group did not have follow-up HbA1c measurements, despite active encouragement.  patients and 36 (34.5% missing) of the transition team patients, despite the best efforts of investigators to obtain completed DTSQc questionnaires. We believe the non-random nature of missing data was largely due to factors related to the transition team group, particularly difficulties involved in attending appointments at hospital. However, it may be that patients failing to complete the DTSQc were less satisfied with treatment, suggesting that this was more likely in the transition team group. A significantly higher number of male participants failed to complete the DTSQc, and missing data were higher in those patients with hypertension and dyslipidaemia. The difficulty in obtaining this data raises concerns about the feasibility of using this method to assess treatment satisfaction in patients recently hospitalised with acute illness.
Withdrawal of participants from the transition team in hospital prior to the intervention may reflect reluctance in hospitalized patients to accept health providers entering their home, which may be a limitation of this model.

Study implications
Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to improve outcomes over the course of disease. Escalating rates of diabetes necessitates the development of feasible alternative models of care, with the potential to improve clinical outcomes and health care costs. This study has investigated one such option, and has demonstrated feasibility, improved treatment satisfaction, and a trend to reduced length of stay, with no safety concerns detected.

Conclusion
The results of this novel pilot study suggest that use of a transition team provides a feasible alternative model of care for patients with type 2 diabetes requiring initiation of injectable therapies. More research is necessary to validate these findings in larger populations, and to ascertain whether it may lead to reduced length of stay and healthcare costs.
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Study participation ceased at the 16-week endocrinology appointment, and final data collection 166 occurred. Further follow-up for ongoing diabetes management was arranged at conclusion of the 167 study.

195
The feasibility of the intervention was estimated as a proportion of participants in the transition 196 team group completing the intervention as per protocol with corresponding 95% confidence 197 interval (95% CI).

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The difference in safety profiles (diabetes related hospital presentation or admission) between two 199 groups was investigated using Fisher's exact test.  Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 206 rank-sum test.

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All statistical tests were two sided and were performed at a significance level of α = 0.05. Statistical analysis was performed on both intention to treat and per protocol bases. Per protocol 211 analysis was deemed necessary to account for the patients who were initially assigned to 212 transition team but withdrew prior to intervention; in this situation they received standard care. performed, and this will be reported separately.

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Following publication of our findings, the paper outlining study results will be sent to the study 225 participants.

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One hundred and five participants were randomised to transition team or standard care. Following

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One participant in the transition team group was unable to be followed up as they were being 240 actively palliated for terminal malignancy, and one died before completion of the trial, for reasons 241 unrelated to diabetes. One participant withdrew from the standard care group and one died before 242 final data analysis in this group.

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Baseline characteristics of participants are outlined in There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 251 care) and one for inability to cope with insulin management at home due to change in social 252 circumstances (transition team). Neither participant was admitted.      satisfaction with treatment (14,15,16). Interpretability of this parameter is limited by missing 302 data, and there is potential for bias due to some data being obtained over the phone by a research 303 assistant, rather than in person.

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Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 306 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical difference 307 detected between the reduction in HbA1c in the transition team and the standard care group.                 How participants were identified and consented 4 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5 6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed 6 Outcomes 6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a 6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a 7a Rationale for numbers in the pilot trial 6 Sample size 7b When applicable, explanation of any interim analyses and stopping guidelines n/a Randomisation: 8a Method used to generate the random allocation sequence 5 Sequence generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 5 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 5   injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling  The feasibility of the intervention was estimated as a proportion of participants in the 208 transition team group completing the intervention as per protocol with corresponding 95% 209 confidence interval (95% CI).

210
The difference in safety profiles (diabetes related hospital presentation or admission) between 211 two groups was investigated using Fisher's exact test.

212
DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 213 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 214 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the 215 auxillary variables demonstrating significant association with the DTSQ data being missing, 216 into the median regression model.

217
Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 218 rank-sum test.

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All statistical tests were two sided and were performed at a significance level of α = 0.05.

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Statistical analysis was performed on both intention to treat and per protocol bases. Per 223 protocol analysis was deemed necessary to account for the patients who were initially 224 assigned to transition team but withdrew prior to intervention; in this situation they received 225 standard care.

243
One hundred and five participants were randomised to transition team or standard care. analysis, these participants crossed over to the standard care group.

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One participant in the transition team group was unable to be followed up as they were being 253 actively palliated for terminal malignancy, and one died before completion of the trial, for 254 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 255 died before final data analysis in this group.

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Baseline characteristics of participants are outlined in Table 1 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 264 care) and one for inability to cope with insulin management at home due to change in social 265 circumstances (transition team). Neither participant was admitted.    The results pertaining to the quality of this intervention are supported by results from other limited by missing data, and there is potential for bias due to some data being obtained over 316 the phone by a research assistant, rather than in person.

318
Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 319 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 320 difference detected between the reduction in HbA1c in the transition team and the standard 321 care group.              How participants were identified and consented 4 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5 6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed 6 Outcomes 6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a 6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a 7a Rationale for numbers in the pilot trial 6 Sample size 7b When applicable, explanation of any interim analyses and stopping guidelines n/a Randomisation: 8a Method used to generate the random allocation sequence 5 Sequence generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 5 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 5    injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling  defined as blood glucose levels between 5-15 mmol/L in the 24 hours prior to randomisation.

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Patients were excluded if they did not fulfil inclusion criteria. Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 137 investigator without patient contact. Group allocations were concealed by writing allocations

215
The difference in safety profiles (diabetes related hospital presentation or admission) between 216 two groups was investigated using Fisher's exact test.  All statistical tests were two sided and were performed at a significance level of α = 0.05.

227
Statistical analysis was performed on both intention to treat and per protocol bases. Per 228 protocol analysis was deemed necessary to account for the patients who were initially 229 assigned to transition team but withdrew prior to intervention; in this situation they received 230 standard care.

246
One hundred and five participants were randomised to transition team or standard care. analysis, these participants crossed over to the standard care group.

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One participant in the transition team group was unable to be followed up as they were being 256 actively palliated for terminal malignancy, and one died before completion of the trial, for 257 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 258 died before final data analysis in this group.

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Baseline characteristics of participants are outlined in Table 1 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 267 care) and one for inability to cope with insulin management at home due to change in social 268 circumstances (transition team). Neither participant was admitted.  The results pertaining to the quality of this intervention are supported by results from other                Settings and locations where the data were collected 5 4c How participants were identified and consented 5, 6 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 6 6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed 6 Outcomes 6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a 6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a 7a Rationale for numbers in the pilot trial 7 Sample size 7b When applicable, explanation of any interim analyses and stopping guidelines n/a Randomisation: 8a Method used to generate the random allocation sequence 5, 6 Sequence generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5, 6 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 5, 6  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  *We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.

61
Missing data may have limited interpretability of results.

68
Consequently, health care costs related to diabetes continue to increase over time (3).

69
It has been demonstrated that 34% of hospital inpatients aged over 54 admitted to a tertiary  Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies,

101
were screened for the study, and randomised to receive the intervention or standard care after 102 providing informed consent. Baseline characteristics of the participants are outlined in table 1.

103
Funding of participants' healthcare is through the Australian government's universal health 104 insurance system, Medicare.

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Participant inclusion criteria were the ability to provide informed consent, the presence of type

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The difference in safety profiles (diabetes related hospital presentation or admission) between 193 two groups was investigated using Fisher's exact test.  All statistical tests were two sided and were performed at a significance level of α = 0.05.

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One hundred and five participants were randomised to transition team or standard care. One participant in the transition team group was unable to be followed up as they were being 232 actively palliated for terminal malignancy, and one died before completion of the trial, for 233 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 234 died before final data analysis in this group.

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Baseline characteristics of participants are outlined in Table 1. No differences between groups 236 at baseline were identified. There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 243 care) and one for inability to cope with insulin management at home due to change in social 244 circumstances (transition team). Neither participant was admitted. an intervention on satisfaction with treatment (15,16,17). Interpretability of this parameter is 294 limited by missing data, and there is potential for bias due to some data being obtained over the 295 phone by a research assistant, rather than in person.

229
One hundred and five participants were randomised to transition team or standard care.

230
Following initial drop outs, 103 participants received the intervention or standard care ( Figure   231 1 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 250 care) and one for inability to cope with insulin management at home due to change in social 251 circumstances (transition team). Neither participant was admitted.    The results pertaining to the quality of this intervention are supported by results from other limited by missing data, and there is potential for bias due to some data being obtained over the 302 phone by a research assistant, rather than in person.

304
Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 305 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 306 difference detected between the reduction in HbA1c in the transition team and the standard care 307 group.

Methods 3a
Description of pilot trial design (such as parallel, factorial) including allocation ratio 5, 6 Trial design 3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 6 4a Eligibility criteria for participants 5 Participants 4b Settings and locations where the data were collected 5 4c How participants were identified and consented 5, 6 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 6 6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed 6 Outcomes 6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a 6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a 7a Rationale for numbers in the pilot trial 7 Sample size 7b When applicable, explanation of any interim analyses and stopping guidelines n/a Randomisation: 8a Method used to generate the random allocation sequence 5, 6 Sequence generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5, 6 Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 5, 6 F o r p e e r r e v i e w o n l y Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 5, 6 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how n/a Blinding 11b If relevant, description of the similarity of interventions 6 Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 7

Results
13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly assigned, received intended treatment, and were assessed for each objective 9 Participant flow (a diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 9 14a Dates defining the periods of recruitment and follow-up 5 Recruitment 14b Why the pilot trial ended or was stopped 5 Baseline data 15 A  *We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.