N/A
N=68
ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
Diabetes Mellitus, Type 1 · Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03651622 ↗Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Mar 2022
Primary outcome: Primary: Change in Weight - Randomization 1 — -1.6; -1.8; -1.5 kilograms — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypocaloric, low carbohydrate diet (Behavioral); Hypocaloric, moderate low fat diet (Behavioral); Mediterranean diet, no caloric restriction (Behavioral)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight - Randomization 1 |
-1.6; -1.8; -1.5 | 0.98 |
| PRIMARY Change in Weight - Randomization 2 |
0.27; 0.99; 0.86 | 0.85 |
| PRIMARY Change in Weight - Randomization 3 |
0.68; -0.85; -0.64 | 0.40 |
| PRIMARY Change in HbA1C - Randomization 1 |
-0.03; -0.48; 0.37 | 0.02 sig |
| PRIMARY Change in HbA1C - Randomization 2 |
-0.11; -0.008; -0.36 | 0.38 |
| PRIMARY Change in HbA1C - Randomization 3 |
0.25; 0.72; -0.16 | 0.18 |
| PRIMARY Change in Time in Clinical Hypoglycemia - Randomization 1 |
-0.30; 0.65; -0.45 | 0.79 |
| PRIMARY Change in Time in Clinical Hypoglycemia - Randomization 2 |
0.2; 1.4; 2.6 | 0.39 |
| PRIMARY Change in Time in Clinical Hypoglycemia - Randomization 3 |
0.086; 0.97; -0.47 | 0.75 |
| SECONDARY Change in Body Fat - Randomization 1 |
-0.87; -0.058; -0.57 | 0.66 |
| SECONDARY Change in Body Fat - Randomization 2 |
-0.38; -0.28; 0.05 | 0.96 |
| SECONDARY Change in Body Fat - Randomization 3 |
1.4; 0.1; -0.9 | 0.34 |
| SECONDARY Change in Time in Target Glucose Range - Randomization 1 |
6.3; 3.8; -0.96 | 0.58 |
| SECONDARY Change in Time in Target Glucose Range - Randomization 2 |
-0.60; 0.90; 1.0 | 0.95 |
| SECONDARY Change in Time in Target Glucose Range - Randomization 3 |
-2.1; -18.4; 1.1 | 0.08 |
Summary
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.
COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
Eligibility Criteria
Inclusion Criteria
- Individuals 19-30 years old at enrollment
- History of Type 1 diabetes for greater than one year
- Latest hemoglobin A1c less than 13%
- BMI of 27-39
Exclusion Criteria
- Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
- Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
- Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
- Individuals unwilling to follow any of the three study diets
- Individuals who monitor blood glucose less than 3 times a day
Data sourced from ClinicalTrials.gov (NCT03651622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.