Methods: A two arm, individually randomized, pilot superiority trial for adults with intellectual disability and Type 2 diabetes mellitus (DM). A total of 66 adults with disabilities across the UK met the eligibility criteria. Of these 39 agreed to participate and were randomly assigned to either the DESMOND-ID programme (N=19) or a control group (N= 20). The programme consisted of 7-weekly educational sessions. Primary outcome was HbA1c, secondary outcomes included BMI, diabetes illness perceptions, severity of diabetes, quality of life, and attendance rates.
Results: This study found that the DESMOND-ID programme was feasible to deliver. With reasonable adjustments, the participants could be successfully recruited, consented, completed the outcome measures, be randomized to the groups, attend most of the sessions and have minimal loss to follow-up. Based on the results from a fixed-effects model the interaction between occasion (time) and condition, the result for HbA1c was statistically significant (0.05 level); however, the confidence interval was large.
Conclusion: This is the first published study to adapt and pilot a national structured self-management diabetes education programme for this population. This study shows it is possible to identify, recruit, consent and randomize adults with intellectual disabilities to an intervention or control group. Internationally, the results of this pilot are promising: demonstrating that a multi-session education programme is acceptable, feasible to deliver, and that its effectiveness should be tested in an adequately powered trial.